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    The EU Clinical Trials Register currently displays   35238   clinical trials with a EudraCT protocol, of which   5761   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-002412-10
    Sponsor's Protocol Code Number:D5892C00012
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2006-002412-10
    A.3Full title of the trial
    A randomized, double-blind, double-dummy, two-way cross-over
    study evaluating systemic bioavailability and airway clearance of
    Symbicort® Turbuhaler® 320/9μg/inhalation versus Seretide™ Diskus
    ™50/500μg/inhalation after single inhalations in patients with Chronic
    Obstructive Pulmonary Disease (COPD) and healthy volunteers
    A.3.2Name or abbreviated title of the trial where available
    Airway clearance
    A.4.1Sponsor's protocol code numberD5892C00012
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Symbicort Turbuhaler 320/9 microgram/inhalation
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSymbicort Turbuhaler 320/9 microgram/inhalation
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.3Other descriptive namebudesonide 320 microgram/inhalation
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNformoterol fumarate dihydrate
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameformoterol 9 microgram/inhalation
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Seretide Diskus 50/500 microgram/inhalation
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSeretide Diskus 50/500 microgram/inhalation
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsalmeterol xinafoate
    D.3.9.1CAS number 89365-50-4
    D.3.9.3Other descriptive namesalmeterol 50 microgram/inhalation
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive namefluticasone 500 microgram/inhalation
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This is a Clinical Pharmacology study to be conducted in one patient group with severe COPD and one group of healthy volunteers.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate airway tissue availability of budesonide via Symbicort Turbuhaler and fluticasone via Seretide Diskus in severe COPD patients and healthy volunteers, using area under the curve (AUC) of the plasma concentrations of the steroid components as surrogate marker.
    E.2.2Secondary objectives of the trial
    In addition to the primary objective there is a number of planned exploratory analyses:
    - to investigate the amount of fluticasone and budesonide (% of delivered dose)
    spontaneously expectorated in sputum.
    - to investigate correlation between weight of spontaneously expectorated sputum
    and AUC for budesonide and fluticasone.
    - to investigate correlation between baseline lung function in COPD patients and
    AUC for plasma concentrations of budesonide and fluticasone
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    COPD patients:
    1. Provision of written informed consent obtained prior to study procedures
    2. Outpatients, men or women ≥ 40 years of age
    3. A clinical diagnosis of COPD with symptoms for more than 1 year
    4. A current or previous smoker with a smoking history equivalent to 10 or more
    pack years (1 pack year = 20 cigarettes smoked per day for one year)
    5. Pre-bronchodilatory FEV1 ≤ 55% of predicted normal value
    6. Pre-bronchodilatory FEV1 / VC ≤ 70%
    7. Stable symptoms without signs of infection and COPD exacerbation within 1
    month prior to the study
    8. Productive cough with expectoration two times or more before noon on most days
    9. Ability to inhale from Turbuhaler and Diskus according to given instructions, as
    judged by the investigator or study nurse
    10. Body Mass Index (BMI) between 18 and 32 kg/m2

    Healthy volunteers:
    1. Provision of written informed consent obtained prior to study procedures
    2. Men or women ≥18 years of age
    3. Body Mass Index (BMI) between 18 and 32 kg/m2
    4. Healthy, as judged by the investigator after medical history, physical examination,
    vital signs, electrocardiogram (ECG), and laboratory tests
    5. Pre-bronchodilatory FEV1 > 80% of predicted normal value
    6. Pre-bronchodilatory FEV1 / VC > 70%
    7. Ability to inhale from Turbuhaler and Diskus according to given instructions, as
    judged by the investigator or study nurse
    8. Non-smoker, have never been regular smoker
    E.4Principal exclusion criteria
    COPD patients:
    1. A history of asthma and/or seasonal allergic rhinitis before 40 years of age
    2. Any current respiratory tract disorder other than COPD for example bronchiectasis,
    which is considered by the investigator to be clinically significant
    3. Any clinically relevant abnormal findings in physical examination and vital signs,
    which in the opinion of the investigator, may put the patient at risk because of
    his/her participation in the study
    4. Any significant disease or disorder (e.g. gastrointestinal, liver, renal, neurological,
    musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical
    impairment) which, in the opinion of the investigator, may either put the patient
    at risk because of participation in the study, or may influence the results of the
    study, or the patients ability to participate in the study
    5. Patients with significant or unstable ischemic heart disease, arrhythmia,
    cardiomyopathy, heart failure, uncontrolled hypertension as defined by the
    investigator, or any other relevant cardiovascular disorder as judged by the
    investigator
    6. Use of oral or ophthalmic non-cardio selective β-blocking agents
    7. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
    not using acceptable contraceptive measures, as judged by the investigator.
    8. Known or suspected hypersensitivity to study therapy or excipients of the
    investigational products.
    9. Patients with a history of chronic alcohol or drug abuse or any condition associated
    with poor compliance
    10. Blood donation within 3 months prior to enrolment
    11. Planned hospitalization during the study
    12. Previously enrolled in the present study
    13. Participation in another clinical study within 90 days preceding enrolment
    14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)

    Healthy volunteers:
    1. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
    not using an acceptable contraceptive, as judged by the investigator. All women
    must show a negative pregnancy urine test result at Visit 1.
    2. Known or suspected hypersensitivity to glucocorticosteroids, β2-adrenergic
    agonists, inhaled lactose, or other excipients in study drugs
    3. History and/or evidence of any significant disease or disorder (e.g. respiratory,
    cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal,
    endocrine, metabolic, malignant, psychiatric, major physical impairment) which,
    in the opinion of the investigator, may either put the subject at risk because of
    participation in the study, or may influence the results of the study, or the subject’s
    ability to participate in the study. Evidence of HIV or hepatitis B or C-infection.
    4. Significant illness as judged by the investigator or intake of any prescribed
    medication within two weeks prior to enrolment .
    5. Use of any regular medication or therapy, including over-the-counter remedies,
    herbal preparations, vitamins, and mineral supplements 2 weeks prior to enrolment.
    6. Blood donation within 3 months prior to enrolment
    7. Planned in-patient hospitalization
    8. Abuse of drugs or alcohol or any other condition associated with poor compliance
    9. Previously enrolled in the present study
    10. Participation in another clinical study within 90 days preceding enrolment
    11. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is AUC for fluticasone and budesonide plasma concentrations in COPD patients and healthy volunteers.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-18
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